1. Field of the Invention
The present invention relates to sterilizable medical implant package inserts that provide enhanced protection of the implant during shipment and easier access of the implant at their destination.
2. Description of the Related Art
Due to the diminutive size and fragile nature of many medical implants, such as otologic implants and ventilation tubes, sterilization/shipping containers must provide protection of the implant, be constructed of materials that retain sterile properties and offer ease of handling to the physician and operating nurses.
Typical existing containers include a depression that is larger than the implant itself. The implant is simply placed in the depression. While such containers may satisfy sterility requirements, they, by nature of design, allow the implants to freely shift positions while in the container. This freedom of movement of the implant within the container tends to damage the implant during shipment. Even if the implant has survived the shipment and arrived at the operating room undamaged, an abrupt opening of the container lid will tend to eject and damage the implant. In addition, the fragile implants are frequently damaged during attempts at their removal from the container, which is often performed by grasping the unsecured implants with forceps while stabilizing the implants by forcing them against the wall of the container.
U.S. Pat. No. 5,176,258 to Antal describes a package which includes a peripheral flange around a blister defining an open cavity for receiving a product and a compressible insert for securing the product against movement in the cavity. The Antal patent defines the blister type package with specific reference to sealed packages, and more specifically to an improved method for sealing. Although reference to medical parts is mentioned, the general theme of the Antal disclosure refers to the process of sealing the package and providing a hermetical seal of that package. In addition, Antal teaches a package and associated package opening procedure whereby the medical device is allowed to drop freely from the package onto a sterile field. Such a dropping technique is not desirable for fragile medical implants.
U.S. Pat. No. 5,148,920 to Walker describes a package including a receptacle containing an opening and defining a space for the product and an insert defining an aperture for the product. When the product is in the insert and the insert within the receptacle, a portion of the insert is between the product and cap over the opening, thereby providing a positive restraint against movement of the product. The package configuration of this invention is particularly aimed at medical implants and instruments. The general theme of the Walker disclosure is to provide a modular system by which different inserts can be provided for the same container to secure different sized products and protect them from abrasion and shock while providing access to the product. The Walker package, however, still requires that the operating room personnel lift the insert out of the container in order to free the medical implant. Further, as the insert contacts the implant, damage to fragile inserts could readily result when the insert contacts the implant. In addition, numerous steps are required to access the implant, increasing the likelihood of damage. Finally, Walker requires that the implant and packaging materials be sterilized prior to packaging, thereby increasing handling difficulties during manufacture. The implant is not automatically presented when the container is opened.
There still exists a need for a medical implant packaging system that is sterilizable, protects and secures fragile implants, automatically presents the implants to operating room personnel in an easily accessible manner as the container is opened, and requires a minimum of handling of either the package or implant during manufacture and in the operating room.